Kura Oncology and Kyowa Kirin have announced a global strategic collaboration focused on the development and commercialization of ziftomenib, Kura’s selective oral menin inhibitor. This collaboration aims to address acute myeloid leukemia (AML) and other hematologic malignancies, combining Kura's precision medicine approach with Kyowa Kirin's global pharmaceutical expertise.
Financial Terms and Collaboration Structure
Under the agreement, Kura Oncology will receive an upfront payment of $330 million and is slated to receive up to $420 million in near-term milestone payments, which includes a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory (R/R) setting. Furthermore, Kura is eligible for additional development, regulatory, and commercial milestone payments potentially reaching $741 million, bringing the total milestone payments to $1.161 billion. In the U.S., Kura will spearhead the development, regulatory, and commercial strategies, while both companies will jointly execute commercialization activities, sharing profits and losses equally. Outside the U.S., Kyowa Kirin will lead development, regulatory, and commercial strategies and will be responsible for commercializing ziftomenib. Kura is eligible to receive tiered double-digit royalties on net product sales outside the U.S.
Ziftomenib: A Promising Menin Inhibitor
Ziftomenib is an investigational therapy targeting genetically defined AML patients. It has received Breakthrough Therapy Designation from the FDA for the treatment of R/R NPM1-mutant AML, a mutation associated with poor outcomes. Enrollment in a phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and the companies anticipate submitting a New Drug Application (NDA) in 2025. Kura is also evaluating ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML, with registrational phase 3 frontline studies planned for 2025.
Strategic Rationale and Future Plans
Yasuo Fujii, chief strategy officer of Kyowa Kirin, stated that ziftomenib is a promising treatment for genetically defined AML patients and will complement Kyowa Kirin’s existing hemato-oncology portfolio. Troy Wilson, president and CEO of Kura Oncology, emphasized that this collaboration advances Kura’s goal of building a sustainable biopharmaceutical company and realizes the potential of precision medicines for cancer treatment. The collaboration includes plans to launch multiple phase 2 and phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years. The companies will share responsibility for clinical trials, with Kura funding development costs until the end of 2028, after which costs will be shared equally.
Kyowa Kirin also has an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumors (GIST) and other solid tumor indications, contingent upon clinical data from an ongoing proof-of-concept study. If exercised, Kura is eligible for upfront and milestone payments totaling $228 million.
